MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC): a Pilot Study (TOXTAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01246856
First received: November 22, 2010
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

Many patients with breastcancer in the past, were treated with TAC. These last years, there is more and more focus on the effects of chemotherapy, particularly in children treated with this. One of these effects is damage to the heart muscle, which ultimately might affect the pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has not been previously investigated. The possibility exists that the adverse reactions in children are found in adults also could occur. Therefore we have initiated this trial.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Given the lack of data on the incidence of subclinical cardiotoxicity after treatment with TAC we want to assess whether subclinical cardiovascular damage is present in adult patients with breast cancer who have completed treatment with (neo)adjuvant TAC one year previously, using MIBG (meta-iodobenzylguanidine) scintigraphy, novel echocardiographic techniques and blood biomarkers. Following the study by Lipshultz et al. we expect to find at least in 25% of the patients signs of subclinical cardiovascular damage with at least one of the three techniques.(11) If at least 10% is observed we will conclude that it is useful to further pursue the use of these techniques for the detection of subclinical cardiotoxicity in a next clinical study which will be powered to assess the predictive value of these techniques for the development of clinical heart failure. If a lower percentage is observed we will conclude that it is not useful to further pursue the use of these techniques for the detection of subclinical cardiotoxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients who have been treated with TAC one year previously

Criteria

Inclusion Criteria:

  • Female patients with breast cancer, ≥ 18 years old at the time of breast cancer diagnosis
  • (Neo)adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide (TAC) completed one year before inclusion

Exclusion Criteria:

  • Evidence of breast cancer recurrence or metastatic disease
  • Evidence of heart disease at the time of breast cancer diagnosis
  • Evidence of renal failure at the time of cardiac evaluation
  • Pregnant or lactating
  • Participation in a research protocol with ionizing radiation within one year before inclusion.
  • Evidence of diabetes mellitus or Parkinson's disease
  • Evidence of an MIBG-accumulating tumor (pheochromocytoma, paraganglioma, chemodectoma, ganglioneuroma, neuroblastoma, carcinoid, medullary thyroid cancer, neurofibromatosis, retinoblastoma, esthesioneuroma, schwannoma, merkelcel-tumor, pancreatic islet cell tumors, small cell lung carcinoma, melanoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246856

Contacts
Contact: H.W.M. van Laarhoven, Md +31 24 361 03 53 h.vanlaarhoven@onco.umcn.nl
Contact: L.F. de Geus-Oei, Md +31 24 365 53 40 L.deGeus-Oei@nucmed.umcn.nl

Locations
Netherlands
University Medical Centre Nijmegen Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Principal Investigator: H.W.M. van Laarhoven, Md         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: H.W.M. van Laarhoven, Md University Medical Centre Nijmegen
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01246856     History of Changes
Other Study ID Numbers: UMCNONCO201005
Study First Received: November 22, 2010
Last Updated: September 9, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Cardiotoxicity
Breast cancer treatment
MIBG scintigraphy
Strain Echocardiography
patients who have been treated with TAC one year previously

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on April 17, 2014